AzTrials
AzTrials

HIV InfectionsPhase 1NCT04563845

Effect of Therapeutic and Supratherapeutic Oral Doses of GSK3640254 on Cardiac Conduction Compared to Placebo and a Single Oral Dose of Moxifloxacin

A Phase 1 study testing GSK3640254 and Moxifloxacin in people with HIV Infections, run by ViiV Healthcare at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will aim to evaluate the effect of therapeutic and supratherapeutic oral doses of GSK3640254 on cardiac conduction compared to placebo and a single oral dose of Moxifloxacin in healthy adult participants. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
GSK3640254 and Moxifloxacin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteUnited States
Study dates
9 Nov 2020to 30 Oct 2021
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participant must be 18 to 50 years of age inclusive, at the time of signing the informed consent.
  • Participants who are healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination (including cardiopulmonary examination), laboratory tests, and cardiac monitoring (history and ECG).
  • Body weight more than or equal to (>=)50.0 kilograms (kg) (110 pounds [lbs]) for men and >=45.0 kg (99 lbs) for women and body mass index within the range 18.5 to 31.0 kilograms per square meter (kg/m^2) (inclusive).
  • Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Male or female participants:
  • Male participants should not engage in intercourse while confined in the clinic. There is no need for an extended period of double barrier use or prolonged abstinence after study discharge.
Show all 10Show fewer
  • Female participants:
  • A female participant is eligible to participate if she is not pregnant, planning to become pregnant within the next 6 months, or breastfeeding, and at least 1 of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and using a non-hormonal contraceptive method that is highly effective, with a failure rate of less than (<)1 percent (%) for 28 days before intervention, during the intervention period, and for at least 28 days after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
  • A WOCBP must have a negative highly sensitive serum pregnancy test at Screening and Check-in.
  • Capable of giving signed informed, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol.

Who cannot join

  • Participants with current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • A pre-existing condition interfering with normal Gastrointestinal (GI) anatomy or motility (for example [e.g.], gastro-esophageal reflux disease, gastric ulcers, gastritis), hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study intervention or render the participant unable to take oral study intervention.
  • Prior cholecystectomy (prior appendectomy is acceptable).
  • Clinically significant illness, including viral syndromes, within 3 weeks of dosing.
  • A participant with known or suspected active Coronavirus Disease-2019 (COVID-19) infection OR contact with an individual with known COVID-19, within 14 days of study enrollment (World Health Organization [WHO] definitions).
  • Any history of significant underlying psychiatric disorder, including, but not limited to, schizophrenia, bipolar disorder with or without psychotic symptoms, other psychotic disorders, or schizotypal (personality) disorder.
Show all 45Show fewer
  • Any history of major depressive disorder with or without suicidal features, or anxiety disorders that required medical intervention (pharmacologic or not) such as hospitalization or other inpatient treatment and/or chronic (more than [>]6 months) outpatient treatment. Participants with other conditions such as adjustment disorder or dysthymia that have required shorter term medical therapy (<6 months) without inpatient treatment and are currently well-controlled clinically or resolved may be considered for entry after discussion and agreement with the ViiV Healthcare/GlaxoSmithKline (VH/GSK) Medical Monitor.
  • Any pre-existing physical or other psychiatric condition (including alcohol or drug abuse), which, in the opinion of the investigator (with or without psychiatric evaluation), could interfere with the participant's ability to comply with the dosing schedule and protocol evaluations or which might compromise the safety of the participant.
  • Medical history of cardiac arrhythmias, prior myocardial infarction in the past 3 months, or cardiac disease or a family or personal history of long QT syndrome.
  • History indicative of an increased risk of a cardiac arrhythmia or cardiac disease, including the following:
  • History of symptomatic cardiac arrhythmias or palpitations associated with pre-syncope or syncope, or history of unexplained syncope.
  • History of cardiac arrest.
  • History of clinically relevant cardiac disease including symptomatic or asymptomatic arrhythmias (including but not limited to ventricular fibrillation, ventricular tachycardia, any degree of atrioventricular block, Brugada syndrome, Wolff-Parkinson-White Syndrome, and sinus bradycardia, defined as HR less than 50 bpm based on vital signs or ECG), presyncope or syncopal episodes, or additional risk factors for torsades de pointes (e.g., heart failure).
  • History of clinically relevant structural cardiac disease including hypertrophic obstructive cardiomyopathy.
  • History of hypokalemia.
  • History of heart disease (e.g., coronary heart disease, angina).
  • Presence of hepatitis B surface antigen at Screening or within 3 months prior to starting study intervention.
  • Positive hepatitis C antibody test result at Screening or within 3 months prior to starting study intervention.
  • Positive Human Immunodeficiency virus (HIV)-1 and -2 antigen/antibody immunoassay at Screening.
  • Alanine aminotransferase (ALT) >=1.5 times upper limit of normal (ULN). A single repeat of ALT is allowed within a single Screening period to determine eligibility.
  • Bilirubin >=1.5 times ULN (isolated bilirubin >=1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). A single repeat of any laboratory abnormality is allowed within a single Screening period to determine eligibility.
  • Any acute laboratory abnormality (including hypokalemia, hypercalcemia, or hypomagnesemia) at Screening which, in the opinion of the investigator, should preclude participation in the study of an investigational compound.
  • Any Grade 2 to 4 laboratory abnormality at Screening, with the exception of lipid abnormalities (e.g., total cholesterol, triglycerides), and ALT (previously described), will exclude a participant from the study unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the sponsor. A single repeat of any laboratory abnormality is allowed within a single Screening period to determine eligibility.
  • Urine drug screen positive (showing presence of): amphetamines, barbiturates, cocaine, Methylenedioxymethamphetamine (MDMA), cannabinoids, methamphetamines, phencyclidine, or non-prescribed opiates, oxycodone, benzodiazepines, methadone, or tricyclic antidepressants at screening or before dosing of study intervention.
  • Unable to refrain from the use of prescription or nonprescription drugs including vitamins, herbal and dietary supplements (including Saint [St] John's wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study intervention and for the duration of the study.
  • Treatment with any vaccine within 30 days prior to receiving study intervention.
  • Unwillingness to abstain from consumption of any food or drink containing grapefruit and grapefruit juice, Seville oranges, blood oranges, or pomelos or their fruit juices within 7 days prior to the first dose of study intervention(s) until the end of the study.
  • Participation in another concurrent clinical study or prior clinical study (with the exception of imaging trials) prior to the first dosing day in the current study: 30 days, 5 half-lives, or twice the duration of the biological effect of the study intervention (whichever is longer).
  • Prior exposure to GSK3640254 in this or another clinical study.
  • Prior intolerance to Moxifloxacin.
  • Prior participation in this clinical study (participants may not participate in both Part 1 and Part 2 of the study).
  • Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 56 days.
  • Any positive (abnormal) response confirmed by the investigator on a screening clinician- or qualified designee-administered Columbia-Suicide Severity Rating Scale (C-SSRS).
  • A sustained supine systolic blood pressure >150 millimeters of mercury (mm Hg) or <90 mm Hg or a supine diastolic blood pressure >95 mm Hg or <50 mm Hg at Screening or Check-in (Day -2). Blood pressure may be retested once in the supine position. The blood pressure abnormality is considered sustained if either the systolic or the diastolic pressure values are outside the stated limits after 2 assessments, in which case the participant may not be randomized.
  • A resting HR of <50 bpm or >100 bpm when vital signs are measured at Screening or Check-in (Day -2). A HR from 100 to 110 bpm can be rechecked by ECG or vital signs within up to 2 hours to verify eligibility.
  • An uninterpretable ECG or any significant arrhythmia or ECG finding (e.g., prior myocardial infarction in the past 3 months, significant pathological Q-waves (defined as Q-wave >40 ms or depth greater than 0.4-0.5 millivolts [mV], symptomatic bradycardia, non-sustained or sustained atrial arrhythmias, ventricular pre-excitation, non-sustained or sustained ventricular tachycardia, any degree of atrioventricular block, complete left bundle branch block, or conduction abnormality) which, in the opinion of the investigator or VH/GSK Medical Monitor, will interfere with the safety of the individual participant.
  • Exclusion criteria for Screening ECG (a single repeat is allowed for eligibility determination):
  • HR: <50 or >100 bpm (ii) QTcF interval1: >450 ms (iii) QRS interval: >110 ms (iv) PR interval: >200 ms
  • Screening Holter (24 hours) with any of the following:
  • Sinus bradycardia less than or equal to (<=)35 bpm or junctional arrhythmia >60 bpm for 10 seconds or longer.
  • Non-sustained ventricular tachycardia or more than 30 ventricular premature depolarizations during an hour.
  • Atrial arrhythmia >100 bpm for 3 seconds or longer or more than 40 atrial premature depolarizations during an hour.
  • History of alcoholism and/or drug/chemical abuse or regular alcohol consumption within 6 months of screening, defined as an average weekly intake of >14 units. One unit is equivalent to 8 grams of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine, or 1 (25 mL) measure of spirits.
  • Unable to refrain from tobacco or nicotine-containing products within 3 months prior to Screening and for the duration of the study.
  • History of sensitivity to any of the study medications or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • GSK Investigational Site

    Austin, Texas, 78744

Other trials in United States

About this study

Official title: A Study to Evaluate the Effect of Therapeutic and Supratherapeutic Oral Doses of GSK3640254 on Cardiac Conduction as Assessed by 12-Lead Electrocardiogram Compared to Placebo and a Single Oral Dose of Moxifloxacin in Healthy Adult Participants

This study will aim to evaluate the effect of therapeutic and supratherapeutic oral doses of GSK3640254 on cardiac conduction compared to placebo and a single oral dose of Moxifloxacin in healthy adult participants. The study has 2 parts: Part 1 will determine the supratherapeutic dose for Part 2, which will be the main corrected QT interval (QTc) study. Part 1 will evaluate once daily (QD) dosing of GSK3640254 or placebo and Part 2 will investigate the safety, tolerability and Pharmacokinetics (PK) of GSK3640254 doses on cardiac conduction as compared to placebo and a single oral dose of Moxifloxacin in healthy adult participants. Moxifloxacin will be included as a positive control.

Conditions
HIV Infections
Being tested
GSK3640254, Placebo, Moxifloxacin
Keywords
GSK3640254, Moxifloxacin, Electrocardiogram, Cardiac Conduction, Supratherapeutic dose
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK3640254Drug

    GSK3640254 will be administered.

  • PlaceboDrug

    Placebo will be administered.

  • MoxifloxacinDrug

    Moxifloxacin will be administered.

Study groups in NCT04563845
Study groupRoleWhat they receive
Part 1: Participants receiving placeboPlacebo comparatorParticipants will receive a single dose of placebo once daily for 7 days following ingestion of a moderate fat meal.
Receives: Drug: GSK3640254; Drug: Placebo
Part 1: Participants receiving GSK3640254 500 milligrams (mg)ExperimentalParticipants will receive a single dose of GSK3640254 500 mg once daily for 7 days following ingestion of a moderate fat meal.
Receives: Drug: GSK3640254
Part 2: Main QTc StudyExperimentalParticipants will be randomized to 1:1:1:1 ratio to receive Treatment T- Therapeutic dose of GSK3640254 (100 mg QD) on Days 1 through 7 or Treatment ST- Supratherapeutic dose of GSK3640254 (to be determined from Part 1) on Days 1 through 7 or Treatment P- Placebo for GSK3640254 on Days 1 through 7 or Treatment M- Moxifloxacin (GSK3640254 placebo Days 1 through 6 and a single dose of Moxifloxacin [400 mg] on Day 7 in 4 treatment periods. There will be at least 7 days wash out period between each period.
Receives: Drug: GSK3640254; Drug: Placebo; Drug: Moxifloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC[0-t]) of GSK3640254

    Blood samples were collected at indicated time points. Pharmacokinetic (PK) analysis was conducted using standard non-compartmental methods.

    Measured: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7

  2. Part 1: AUC From Time Zero to the End of the Dosing Interval at Steady State (AUC[0-tau]) of GSK3640254

    Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.

    Measured: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7

  3. Part 1: Maximum Observed Concentration (Cmax) of GSK3640254

    Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.

    Measured: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7

  4. Part 1: Plasma Concentration at the End of the Dosing Interval (Ctau) of GSK3640254

    Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods

    Measured: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7

  5. Part 1: Time of Maximum Observed Concentration (Tmax) of GSK3640254

    Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.

    Measured: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7

  6. Part 1: Plasma Concentration of GSK3640254

    Blood samples were collected at indicated time points to analyze the plasma concentration of GSK3640254.

    Measured: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7

  7. Part 1: Plasma Concentration of Major Metabolites of GSK3640254

    Blood samples were to be collected at indicated time points to analyze the plasma concentration of major metabolites of GSK3640254.

    Measured: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7

  8. Part 1: Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect as per medical and scientific judgment. Adverse events which were not Serious Adverse Events were considered as Non-Serious adverse events.

    Measured: Up to Day 9

  9. Part 1: Absolute Values for Hematology Parameter: Hemoglobin

    Blood samples were collected at indicated time points to analyze hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day -2), Day 3, Day 7, and Day 9

  10. Part 1: Absolute Values for Hematology Parameter: Hematocrit

    Blood samples were collected at indicated time points to analyze hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day -2), Day 3, Day 7, and Day 9

  11. Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume

    Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day -2), Day 3, Day 7, and Day 9

  12. Part 1: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin

    Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day -2), Day 3, Day 7, and Day 9

  13. Part 1: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes

    Blood samples were collected at indicated time points to analyze basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. .

    Measured: Baseline (Day -2), Day 3, Day 7, and Day 9

  14. Part 1: Absolute Values for Hematology Parameter: Erythrocytes

    Blood samples were collected at indicated time points to analyze erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day -2), Day 3, Day 7, and Day 9

  15. Part 1: Change From Baseline in Hematology Parameter: Hemoglobin

    Blood samples were collected at indicated time points to analyze hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

    Measured: Baseline (Day -2), Day 3, Day 7, and Day 9

  16. Part 1: Change From Baseline in Hematology Parameter: Hematocrit

    Blood samples were collected at indicated timepoints to analyze hemotocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

    Measured: Baseline (Day -2), Day 3, Day 7, and Day 9

  17. Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume

    Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

    Measured: Baseline (Day -2), Day 3, Day 7, and Day 9

  18. Part 1: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin

    Blood samples were collected at idicated time points to analyze erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

    Measured: Baseline (Day -2), Day 3, Day 7, and Day 9

  19. Part 1: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes

    Blood samples were collected at indicated time points to analyze basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

    Measured: Baseline (Day -2), Day 3, Day 7, and Day 9

  20. Part 1: Change From Baseline in Hematology Parameter: Erythrocytes

    Blood samples were collected at indicated time points to analyze the hematology parameter: Erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

    Measured: Baseline (Day -2), Day 3, Day 7, and Day 9

  21. Part 1: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, and Blood Urea Nitrogen

    Blood samples were collected at indicated time points to analyze glucose, cholesterol, magnesium, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium, and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day -2), Day 3, Day 7, and Day 9

  22. Part 1: Absolute Values for Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), Creatine Kinase, and Lactate Dehydrogenase

    Blood samples were collected at indicated time points to analyze ALT, ALP, AST, GGT, creatine kinase, and lactate dehydrogenase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day -2), Day 3, Day 7, and Day 9

  23. Part 1: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, and Direct Bilirubin

    Blood samples were collected at indicated timepoints to analyze creatinine, urate, total bilirubin, and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day -2), Day 3, Day 7, Day 9

  24. Part 1: Absolute Values for Chemistry Parameters: Albumin, Globulin, and Total Protein

    Blood samples were collected at indicated timepoints to analyze albumin, globulin, and total protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day -2), Day 3, Day 7, Day 9

  25. Part 1: Absolute Values for Chemistry Parameters: Amylase and Lipase

    Blood samples were collected at indicated timepoints to analyze amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day -2), Day 3, Day 7, and Day 9

  26. Part 1: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen

    Blood samples were collected at indicated time points to analyze glucose, cholesterol, magnesium, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium, and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

    Measured: Baseline (Day -2), Day 3, Day 7, and Day 9

  27. Part 1: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase

    Blood samples were collected at indicated time points to analyze ALT, ALP, AST, GGT, creatine kinase, and lactate dehydrogenase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

    Measured: Baseline (Day -2), Day 3, Day 7, and Day 9

  28. Part 1: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin

    Blood samples were collected at indicated timepoints to analyze creatinine, urate, total bilirubin, and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

    Measured: Baseline (Day -2), Day 3, Day 7, and Day 9

  29. Part 1: Change From Baseline in Chemistry Parameters: Albumin, Globulin, and Total Protein

    Blood samples were collected at indicated timepoints to analyze albumin, globulin, and total protein. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value

    Measured: Baseline (Day -2), Day 3, Day 7, and Day 9

  30. Part 1: Change From Baseline in Chemistry Parameters: Amylase and Lipase

    Blood samples were collected at indicated timepoints to analyze amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

    Measured: Baseline (Day -2), Day 3, Day 7, and Day 9

  31. Part 1: Absolute Values for Urinalysis Parameter: Specific Gravity

    Urine samples were collected at indicated time points to analyze the urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day -2), Day 3, Day 7, and Day 9

  32. Part 1: Absolute Values for Urinalysis Parameter: Potential of Hydrogen (pH)

    Urine samples were collected at indicated time points to analyze the urine pH by dipstick test. The dipstick test gives results in a semi-quantitative manner indicating proportional concentrations in the urine sample. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day -2), Day 3, Day 7, and Day 9

  33. Part 1: Change From Baseline in Urinalysis Parameter: Specific Gravity

    Urine samples were collected at indicated time points to analyze the urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

    Measured: Baseline (Day -2), Day 3, Day 7, and Day 9

  34. Part 1: Change From Baseline in Urinalysis Parameter: pH

    Urine samples were collected at indicated time points to analyze the urine pH by dipstick test. The dipstick test gives results in a semi-quantitative manner indicating proportional concentrations in the urine sample. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

    Measured: Baseline (Day -2), Day 3, Day 7, and Day 9

  35. Part 1: Number of Participants With Clinically Significant Abnormal 12-Lead Electrocardiogram (ECG) Findings

    A 12-lead ECG was recorded with the participant in a supine position. 12-lead ECGs were obtained by using an automated ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with clinically significant abnormal 12-Lead ECG findings has reported

    Measured: Baseline(Day-2), Day1: 2 Hours, 4 Hours, 6 Hours; Day 4: 2 Hours, 4 Hours, 6 Hours, Day 7: 2 Hours, 4 Hours, 6 Hours and Day 9

  36. Part 1: Absolute Values for Vital Parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

    SBP and DBP were measured in the semi-recumbent or supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Pre-dose, Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8 and Day 9

  37. Part 1: Absolute Values for Vital Parameter: Pulse Rate

    Pulse rate was measured in the semi-recumbent or supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Pre-dose, Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8 and Day 9

  38. Part 1: Absolute Values for Vital Parameter: Temperature

    Temperature was measured in the semi-recumbent or supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions.Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Pre-dose, Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8 and Day 9

  39. Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg Using Concentration-QTc (C-QTc) Analysis

    Twelve-lead ECGs were recorded in participant using automated ECG machine \& performed with participant in supine position after a rest of at least 10 minutes.Baseline was defined as the latest pre-dose assessment with a non-missing value for each visit. Change from Baseline was calculated by subtracting Baseline value from post dose value. Placebo-corrected change from Baseline in QT interval corrected for heart rate using Fridericia's formula (QTcF) was calculated as difference in model-predicted mean change from Baseline in QTcF between treatment groups using C-QTc analysis. A linear mixed-effects model with change from Baseline in QTcF as the dependent variable, time-matched GSK3640254 plasma concentration as a fixed effect, centered Baseline as additional covariate,treatment \&time as categorical factors, \& a random intercept \& slope per participant. In all calculations, concentrations in participants who received placebo were set to 0.

    Measured: Baseline (Pre-dose, Day 1) and up to Day 7

  40. Part 2: Plasma Concentration of GSK3640254

    Blood samples were collected at indicated time points to analyze the plasma concentration of GSK3640254.

    Measured: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each treatment period

  41. Part 2: Plasma Concentration of Major Metabolites of GSK3640254

    Blood samples were to be collected at indicated time points to analyze the plasma concentration of major metabolites of GSK3640254.

    Measured: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each treatment period

Secondary outcomes (49)

  1. Part 2: Change From Baseline in Heart Rate (HR) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms

    Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

    Measured: Baseline (Pre-dose, Day 1), Day 7 : Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose

  2. Part 2: Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms

    Twelve-lead ECGs were recorded in participant using automated ECG machine \& performed with participant in supine position after a rest of at least 10 minutes.Baseline was defined as the latest pre-dose assessment with a non-missing value for each visit. Change from Baseline in QT interval corrected for heart rate using Fridericia's formula (QTcF) was calculated by subtracting Baseline value from post dose value.

    Measured: Baseline (Pre-dose, Day 1), Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose

  3. Part 2: Change From Baseline in PR Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms

    Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

    Measured: Baseline (Pre-dose, Day 1), Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose

  4. Part 2: Change From Baseline in QRS Interval - For GSK3640254 100 mg, GSK3640254 500 mg and Placebo Arms

    Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

    Measured: Baseline (Pre-dose, Day 1), Day 7 : Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose

  5. Part 2: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Using Fridericia's Formula (QTcF) Following Administration of GSK3640254 100 mg and GSK3640254 500 mg By-time Point Analysis

    Twelve-lead ECGs were recorded in participant using automated ECG machine \& performed with participant in supine position after a rest of at least 10 minutes.Baseline was defined as the latest pre-dose assessment with a non-missing value for each visit. Change from Baseline was calculated by subtracting Baseline value from post dose value. Placebo-corrected change from Baseline in QT interval corrected for heart rate using Fridericia's formula (QTcF) was calculated as model-predicted mean change from Baseline in QTcF in GSK3640254 group minus model-predicted mean change from Baseline in QTcF in the placebo group (by-time point analysis). Time point analysis was performed based on a linear mixed-effects model: Change from Baseline in QTcF = Time + Treatment + Time*Treatment +Baseline QTcF + Period + Sequence. An unstructured covariance structure was used to specify the repeated measures (time within participant and period). A random intercept per participant was also included.

    Measured: Baseline (Pre-dose, Day 1), Day 7 : Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose

  6. Part 2: Placebo-corrected Change From Baseline in HR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg

    Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline is defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Placebo-corrected change from Baseline in HR was calculated as model-predicted mean change from Baseline in HR in GSK3640254 group minus model-predicted mean change from Baseline in HR in the placebo group.

    Measured: Baseline (Pre-dose, Day 1) Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose

  7. Part 2: Placebo-corrected Change From Baseline in PR Following Administration of GSK3640254 100 mg and GSK3640254 500 mg

    Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline is defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Placebo-corrected change from Baseline in PR was calculated as model-predicted mean change from Baseline in PR interval in GSK3640254 group minus model-predicted mean change from Baseline in PR interval in the placebo group.

    Measured: Baseline (Pre-dose, Day 1) Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose

  8. Part 2: Placebo-corrected Change From Baseline in QRS Following Administration of GSK3640254 100 mg and GSK3640254 500 mg

    Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Placebo-corrected change from Baseline in QRS was calculated as model-predicted mean change from Baseline in QRS interval in GSK3640254 group minus model-predicted mean change from Baseline in QRS interval in the placebo group.

    Measured: Baseline (Pre-dose, Day 1) Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose

  9. Part 2: Number of Participants With Outlier Results for HR, QTcF, ΔQTcF, PR Interval and QRS Interval for GSK3640254 100 mg and GSK3640254 500 mg

    Twelve-lead ECGs were recorded using an automated ECG machine with participant in a supine position after a rest of at least 10 minutes. Number of participants with outlier results for HR, QTcF, ΔQTcF, PR interval and QRS interval were summarized.Categorical outlier criteria was as follows:change from Baseline in QTcF (ΔQTcF) >60 ms: Increase of QTc from Baseline > 60 ms, QTcF > 500 ms:Treatment-emergent value of > 500 ms when not present at Baseline (new onset), HR < 50 bpm with a decrease in change from Baseline in heart rate (ΔHR) > 25%:Decrease of HR from Baseline >25% resulting in HR < 50 bpm, HR > 100 bpm with an increase in ΔHR > 25% :Increase of HR from Baseline >25% resulting in HR > 100 bpm, PR > 200 ms with an increase in change from Baseline in PR interval (ΔPR) > 25%:Increase of PR from Baseline > 25% resulting in PR > 200 ms, QRS > 120 ms with an increase in change from Baseline in QRS interval (ΔQRS) > 25%:Increase of QRS from Baseline > 25% resulting in QRS > 120 ms.

    Measured: Up to Day 51

  10. Part 2: Number of Participants With Treatment Emergent Changes of T-wave Morphology and Presence of U-wave Following Administration of GSK3640254 100 mg and GSK3640254 500 mg

    Twelve-lead ECGs were recorded using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Flat T-wave=T-amplitude < 1 mm (either positive [+] or negative [-]), including flat isoelectric line, Notched T-wave (+)=Presence of notch(es) of at least 0.05 millivolt (mV) amplitude on ascending or descending arm of the positive T-wave, Biphasic= T-wave that contains a second component with an opposite phase that is at least 0.1 mV deep (both positive/negative and negative/positive and polyphasic T-waves included), Normal T-wave (-)=T-amplitude that is negative, without biphasic T-wave or notches, Notched T-wave (-): Presence of notch(es) of at least 0.05 mV amplitude on descending or ascending arm of the negative T-wave, U-waves= Presence of abnormal U-waves. Data has been reported for Flat T-wave, Notched T-wave (Positive), Biphasic, Normal T-wave (Negative), Notched T-wave (Negative) and T-U wave Fusion.

    Measured: Up to Day 51

  11. Part 2: Placebo-corrected Change From Baseline in QTcF Following Administration of Moxifloxacin

    Twelve-lead ECGs were recorded in participant using an automated ECG machine. Twelve-lead ECGs were performed with the participant in a supine position after a rest of at least 10 minutes. Baseline is defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value. Placebo-corrected change from Baseline in QTcF was calculated as model-predicted mean change from Baseline in QTcF in moxifloxacin group minus model-predicted mean change from Baseline in QTcF in the placebo group.

    Measured: Baseline (Pre-dose, Day 1), Day 7: Predose and 0.5, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 24 Hours post dose

  12. Part 2: AUC(0-t) of GSK3640254 100 mg and GSK3640254 500 mg

    Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods .

    Measured: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each Treatment Period

  13. Part 2: AUC(0-tau) of GSK3640254 100 mg and GSK3640254 500 mg

    Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.

    Measured: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each Treatment Period

  14. Part 2: Cmax of GSK3640254 100 mg and GSK3640254 500 mg

    Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.

    Measured: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each Treatment Period

  15. Part 2: Ctau of GSK3640254 100 mg and GSK3640254 500 mg

    Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.

    Measured: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each Treatment Period

  16. Part 2: Tmax of GSK3640254 100 mg and GSK3640254 500 mg

    Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.

    Measured: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each Treatment Period

  17. Part 2: Cmax of Moxifloxacin 400 mg

    Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods

    Measured: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each treatment period

  18. Part 2: Tmax of Moxifloxacin 400 mg

    Blood samples were collected at indicated time points. PK analysis was conducted using standard non-compartmental methods.

    Measured: Pre-dose and 30 minutes, 1 Hour, 2 Hour, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 8 Hours, 10 Hours, 12 Hours, 24 Hours post-dose on Day 7 in each treatment period

  19. Part 2: Number of Participants With Non-SAEs and SAEs

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect as per medical and scientific judgment. Adverse events which were not Serious Adverse Events were considered as Non-Serious adverse events.

    Measured: Up to Day 51

  20. Part 2: Absolute Values for Hematology Parameter: Hemoglobin

    Blood samples were collected at indicated time points to analyze hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.

    Measured: Baseline (Day -2), Day 8, Day 9, and Day 14

  21. Part 2: Absolute Values for Hematology Parameter: Hematocrit

    Blood samples were collected at indicated time points to analyze hematocrit. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits

    Measured: Baseline (Day -2), Day 8, Day 9, Day 14

  22. Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Volume

    Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits

    Measured: Baseline (Day -2), Day 8, Day 9, Day 14

  23. Part 2: Absolute Values for Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin

    Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.

    Measured: Baseline (Day -2), Day 8, Day 9, Day 14

  24. Part 2: Absolute Values for Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes

    Blood samples were collected at indicated time points to analyze basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.

    Measured: Baseline (Day -2), Day 8, Day 9, Day 14

  25. Part 2: Absolute Values for Hematology Parameter: Erythrocytes

    Blood samples were collected at indicated time points to analyze Erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.

    Measured: Baseline (Day -2), Day 8, Day 9, and Day 14

  26. Part 2: Change From Baseline in Hematology Parameter: Hemoglobin

    Blood samples were collected at indicated time points to analyze hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

    Measured: Baseline (Day -2), Day 8, Day 9, and Day 14

  27. Part 2: Change From Baseline in Hematology Parameter: Hematocrit

    Blood samples were collected at indicated time points to analyze hematocrit . Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

    Measured: Baseline (Day -2), Day 8, Day 9, and Day 14

  28. Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume

    Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular volume. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

    Measured: Baseline (Day -2), Day 8, Day 9, and Day 14

  29. Part 2: Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin

    Blood samples were collected at indicated time points to analyze erythrocytes mean corpuscular hemoglobin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

    Measured: Baseline (Day -2), Day 8, Day 9, and Day 14

  30. Part 2: Change From Baseline in Hematology Parameter: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocytes

    Blood samples were collected at indicated time points to analyze basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

    Measured: Baseline (Day -2), Day 8, Day 9, and Day 14

  31. Part 2: Change From Baseline in Hematology Parameter: Erythrocytes

    Blood samples were collected at indicated time points to analyze erythrocytes. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

    Measured: Baseline (Day -2), Day 8, Day 9, and Day 14

  32. Part 2: Absolute Values for Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen

    Blood samples were collected at indicated time points to analyze glucose, cholesterol, magnesium, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium, and blood urea nitrogen. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit.

    Measured: Baseline (Day -2), Day 8, Day 9, and Day 14

  33. Part 2: Absolute Values for Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase

    Blood samples were collected at indicated time points to analyze ALT, ALP, AST, GGT, creatine kinase, and lactate dehydrogenase. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit.

    Measured: Baseline (Day -2), Day 8, Day 9, and Day 14

  34. Part 2: Absolute Values for Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin

    Blood samples were collected at indicated timepoints to analyze creatinine, urate, total bilirubin, and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit.

    Measured: Baseline (Day -2), Day 8, Day 9, and Day 14

  35. Part 2: Absolute Values for Chemistry Parameters: Albumin, Globulin, Total Protein

    Blood samples were collected at indicated timepoints to analyze albumin, globulin, and total protein. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit.

    Measured: Baseline (Day -2), Day 8, Day 9, and Day 14

  36. Part 2: Absolute Values for Chemistry Parameters: Amylase and Lipase

    Blood samples were collected at indicated timepoints to analyze amylase and lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit.

    Measured: Baseline (Day -2), Day 8, Day 9, and Day 14

  37. Part 2: Change From Baseline in Chemistry Parameters: Glucose, Cholesterol, Magnesium, Triglycerides, Anion Gap, Calcium, Carbon Dioxide, Chloride, Phosphate, Potassium, Sodium, Blood Urea Nitrogen

    Blood samples were collected at indicated time points to analyze glucose, cholesterol, magnesium, triglycerides, anion gap, calcium, carbon dioxide, chloride, phosphate, potassium, sodium, and blood urea nitrogen.Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

    Measured: Baseline (Day -2), Day 8, Day 9, and Day 14

  38. Part 2: Change From Baseline in Chemistry Parameters: ALT, ALP, AST, GGT, Creatine Kinase, Lactate Dehydrogenase

    Blood samples were collected at indicated time points to analyze ALT, ALP, AST, GGT, creatine kinase, and lactate dehydrogenase. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

    Measured: Baseline (Day -2), Day 8, Day 9, and Day 14

  39. Part 2: Change From Baseline in Chemistry Parameters: Creatinine, Urate, Total Bilirubin, Direct Bilirubin

    Blood samples were collected at indicated timepoints to analyze creatinine, urate, total bilirubin, and direct bilirubin. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

    Measured: Baseline (Day -2), Day 8, Day 9, and Day 14

  40. Part 2: Change From Baseline in Chemistry Parameters: Albumin, Globulin, Total Protein

    Blood samples were collected at indicated timepoints to analyze albumin, globulin, and total protein. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

    Measured: Baseline (Day -2), Day 8, Day 9, and Day 14

  41. Part 2: Change From Baseline in Chemistry Parameters: Amylase, Lipase

    Blood samples were collected at indicated timepoints to analyze amylase, lipase. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

    Measured: Baseline (Day -2), Day 8, Day 9, and Day 14

  42. Part 2: Absolute Values for Urinalysis Parameter: Specific Gravity

    Urine samples were collected at indicated time points to analyze the urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit.

    Measured: Baseline (Day -2), Day 8, Day 9, and Day 14

  43. Part 2: Absolute Values for Urinalysis Parameter: pH

    Urine samples were collected at indicated time points to analyze the urine pH by dipstick test. The dipstick test gives results in a semi-quantitative manner indicating proportional concentrations in the urine sample. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit.

    Measured: Baseline (Day -2), Day 8, Day 9, and Day 14

  44. Part 2: Change From Baseline in Urinalysis Parameter: Specific Gravity

    Urine samples were collected at indicated time points to analyze the urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

    Measured: Baseline (Day -2), Day 8, Day 9, and Day 14

  45. Part 2: Change From Baseline in Urinalysis Parameter: pH

    Urine samples were collected at indicated time points to analyze the urine pH by dipstick test. The dipstick test gives results in a semi-quantitative manner indicating proportional concentrations in the urine sample. Urine pH is an acid-base measurement. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acidic pH (5.0 - 6.0). Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visit. Change from Baseline was calculated by subtracting the Baseline value from the post-dose visit value.

    Measured: Baseline (Day -2), Day 8, Day 9, and Day 14

  46. Part 2: Number of Participants With Clinically Significant Abnormal 12-Lead ECG Findings

    A 12-lead ECG was recorded with the participant in a supine position. 12-lead ECGs were obtained by using an automated ECG machine. Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Data for number of participants with clinically significant abnormal 12-Lead ECG findings has reported.

    Measured: Baseline(Day-2), Day1: 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours; Day 2: 24 Hours, Day 4: 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours, Day 5: 24 Hours; Day 7: 1 Hour, 2 Hours, 3 Hours, 4 Hours, 6 Hours; Day 8: 24 Hours; Day 9 and Day 14

  47. Part 2: Absolute Values for Vital Parameters: SBP and DBP

    SBP and DBP were measured in the semi-recumbent or supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.

    Measured: Baseline (Pre-dose, Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, and Day 14

  48. Part 2: Absolute Values for Vital Parameter: Pulse Rate

    Pulse rate was measured in the semi-recumbent or supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.

    Measured: Baseline (Pre-dose, Day 1), Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, and Day 14

  49. Part 2: Absolute Values for Vital Parameter: Temperature

    Temperature was measured in the semi-recumbent or supine position with a completely automated device after at least 5 minutes of rest for the participant in a quiet setting without distractions. Baseline was defined as the latest pre-dose assessment with a non-missing value for each period, including those from unscheduled visits.

    Measured: Baseline (Pre-dose, Day 1), Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10, Day 11, Day 12, Day 13, and Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2020
  2. Study start9 Nov 2020
  3. Primary completion30 Oct 2021
  4. Study completion30 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04563845
Sponsor's protocol ID
213053
Status last verified
Nov 2023
First submitted
18 Sep 2020
Last updated
6 Dec 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

  • Zhang Y, Bush M, Yazdani P, Zhan J, Wen B, Bainbridge V, Wynne BR, Joshi S, Lataillade M. Effects of the HIV-1 maturation inhibitor GSK3640254 on QT interval in healthy participants. Pharmacol Res Perspect. 2023 Dec;11(6):e01151. doi: 10.1002/prp2.1151.

    PubMed 37961928

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK3640254 and Moxifloxacin in people with HIV Infections, run by ViiV Healthcare at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC[0-t]) of GSK3640254 (time frame: Pre-dose and 30 minutes, 1 Hour, 2 Hours, 3 Hours, 3 Hours 30 minutes, 4 Hours, 4 Hours 30 minutes, 5 Hours, 6 Hours, 12 Hours, 24 Hours, 48 Hours post-dose on Day 7). The study lists 41 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04563845, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in